FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX P
MDR report key: 1073326
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02120
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY POST IMPLANT, LOSS OF CAPTURE WAS NOTED WITH AUTOCAPTURE ENABLED. THE OUTPUT WAS CHANGED TO 5 VOLTS IN THE UNIPOLAR CONFIGURATION AND REGULAR CAPTURE WAS OBSERVED. AN X-RAY REVEALED THAT THE LEAD POSITIONING WAS FINE. THE VENTRICULAR CHANNEL WAS LEFT AT HIGH OUTPUT AT 7.5 V, 0.5 MS. THE PATIENT WOULD BE FOLLOWED-UP IN ONE MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX P | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1648T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |